V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec… recallZ-1980-2023 · SenTec AG · initiated May 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SenTec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
FDA root cause category: Device Design
What the company is doing
The recalling firm issued a recall letter dated 5/2/2023 via email on 5/2/2023. The letter explained the reason for recall also stating that the sensors pose no risk to patients but have a high chance of not functioning upon being connected to an SDM monitor. The recalling firm informed the consignee they want to replace the defective sensors. An RMA was enclosed to return the sensor and the shipping confirmation of its replacement.
Recall details
- Recall number
- Z-1980-2023
- Status
- Open, Classified
- Initiated by the company
- May 2, 2023
- Posted by the FDA
- Jun 20, 2023
- Recalling firm
- SenTec AG
- Quantity
- 11 in the U.S.
- Product code
- LKD
- FDA submissions
- K041548
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Product description
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Code information (models, lots, serial numbers)
Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under K041548 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Membrane Changer (reloadable) / single unit MC-RSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer Inserts MC-ISenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- Sentec Digital Monitor SDMSenTec AG · Oximeter, Ear1 report
- Multi-Site Attachment Ring for mature/intact skin MARe-MISenTec AG · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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